Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, received approval from Health Canada for Yesintek™ and Yesintek™ I.V., biosimilars to Stelara® (ustekinumab). This approval holds a major milestone in Biocon's global expansion strategy.
The approval was granted on October 17, 2025, and paves the way for Canadian commercial availability in mid-October. Yesintek™ and Yesintek™ I.V. are indicated for the treatment of moderate to severe plaque psoriasis in adult patients and in pediatric patients (6-17 years of age), active psoriatic arthritis in adults, moderately to severely active Crohn’s disease, and ulcerative colitis in adults, a range of debilitating autoimmune conditions that affect thousands of Canadians.
Health Canada approval was based on a comprehensive data package, confirming that Yesintek™ is highly similar to Stelara with no clinically meaningful differences in efficacy, safety, and immunogenicity. Yesintek™ will be available through the My Biocon Biologics™ patient support program, which provides assistance to individuals prescribed with the therapy. Yesintek™ is available as a subcutaneous injection, 45 mg/0.5 ml (prefilled syringe and vial) and 90 mg/ml (prefilled syringe), and Yesintek™ I.V. as an intravenous solution, 130 mg/26 mL (5 mg/mL).
Executive Statement
According to Shreehas Tambe, CEO & Managing Director of Biocon Biologics, who emphasized the significance of this approval, Health Canada’s approval of Yesintek™ marks a significant milestone in their mission to expand global access to high-quality biosimilars. Building on their successful U.S. launch, this approval strengthens their existence in North America and enhances their immunology portfolio with a more affordable treatment option for Canadian patients living with chronic autoimmune conditions.